Arthrex® AR-9100-09SRecalls & reported problems
Arthrex, Inc. · UNIVERS APEX HUMERAL STEM, 9MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867134553), received between Sep 2, 2020 and Jun 20, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Loose or Intermittent Connection1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9100-09S HUMERAL STEM SCREW WOULD NOT TIGHTEN DOWN THEREFORE THE STEM WOULD NOT SEAT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19574411 ↗InjurySep 2, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS INITIALLY REPORTED VIA THE SURGICAL OUTCOME ALERT SYSTEM THAT A POSSIBLE REVISION MAY HAVE TAKEN PLACE WITH STUDY PATIENT (B)(6). FURTHER INVESTIGATION HAS NOW CONFIRMED THE FOLLOWING INFORMATION: THE STUDY PATIENT HAD A TOTAL SHOULDER ARTHROPLASTY (B)(6) 2018. DUE TO A ROTATOR CUFF/SUBLUXATION, DEFICIENT SUPRASPINATUS AND SUBSCAPULARIS THE PATIENT UNDERWENT A REVISION SURGERY (B)(6) 2018 AT THE SAME FACILITY BY THE SAME SURGEON. DURING THE REVISION SURGERY THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: GLENOID: AR-9106-02. HUMERAL STEM: AR-9100-09S. HUMERAL HEAD: AR-9144-19P. TO COMPLETE THE REVISION SURGERY THE SURGEON USED AND ANTIBIOTIC WASH AFTER REMOVAL OF THE IMPLANTS A BONE ALLOGRAFT WAS USED ON THE GLENOID. HUMERAL CANAL WAS REAMED AND BROACHED IN 30 DEGREES OF RETROVERSION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10483792 ↗
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- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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